Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-31 @ 2:31 AM
Study NCT ID:
NCT01884259
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2012-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2012-05-18', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response Rate (CR, PR)', 'timeFrame': '3 months after end of therapy', 'description': 'RECIST criteria'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (CR, PR, PD, SD)', 'timeFrame': 'until 3 months after therapy', 'description': 'RECIST'}, {'measure': 'Locoregionally monitoring', 'timeFrame': 'after one year'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '1, 2 and 5 years after start of therapy'}, {'measure': 'Adverse reactions', 'timeFrame': 'During treatment and until 60 months after end of radiotherapy', 'description': 'Information about acute toxicity (grade, relation to study drug) during study treatment and until 3 months after end of radiotherapy will be collected for each patient using CTCAE 3.0 criteria list.\n\nInformation about late toxicity (grade) will be collected after 3 months of radiotherapy and until 60 months after radiotherapy using RTOG/EORTC toxicity criteria.\n\nKind and number of toxicities will be described according to grade. The highest grade of each patient and toxicity will be analysed.'}, {'measure': 'Overall-Survival', 'timeFrame': '1, 2 and 5 years after start of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['local advanced squamous cell carcinoma', 'Larynx', 'Hypopharynx', 'Oropharynx', 'Cavum oris', 'docetaxel', 'cisplatin', '5-fluorouracil', 'Cetuximab'], 'conditions': ['Squamous Cell Carcinoma of the Hypopharynx Stage III', 'Squamous Cell Carcinoma of the Hypopharynx Stage IV', 'Squamous Cell Carcinoma of the Larynx Stage III', 'Squamous Cell Carcinoma of the Larynx Stage IV', 'Squamous Cell Carcinoma of the Oropharynx Stage III', 'Squamous Cell Carcinoma of the Oropharynx Stage IV', 'Squamous Cell Carcinoma of the Oral Cavity Stage III', 'Squamous Cell Carcinoma of the Oral Cavity Stage IV']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.agmt.at', 'label': 'Sponsor'}]}, 'descriptionModule': {'briefSummary': 'This multicentre, randomised Phase II Pilot Study evaluates the efficacy of docetaxel, cisplatin and 5-fluorouracil or Cetuximab, followed by Cetuximab with radiotherapy.', 'detailedDescription': 'It will be evaluated whether 5-FU can be replaced by immunotherapy with cetuximab within a taxane/cisplatin-containing induction-chemotherapy scheme for advanced carcinoma of the head and neck. As 5-FU causes severe mucosal toxicities which are added to known toxicities of cisplatin, a combination-therapy with reduced toxicities and same efficacy would be a acceptable alternative to patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris stage III and IV\n* One measureable lesion (CT oder MR)\n* Age 18 - 75 (including)\n* Performance Score ECOG 0 - 1\n\nExclusion Criteria selected:\n\n* Distant metastases\n* ECOG Score \\>1\n* Prior radiation (Head and neck area)\n* Creatinin Clearance below 60 ml/µl\n* Acute infections\n* Neuropathy grade 3 or 4\n* Myocardial Infarction within the last 12 months\n* Acute coronary syndrome or othe clinically significant cardiovascular diseases'}, 'identificationModule': {'nctId': 'NCT01884259', 'acronym': 'HNO-2', 'briefTitle': 'Induction Chemotherapy With TP+5-FU or TP+Cetuximab Followed by Radioimmuptherapy for Locally Advanced or Not Resectable SCCHNN', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'Randomised Phase II Pilot Study: Induction Chemotherapy With Docetaxel, Cisplatin and Cetuximab Versus Docetaxel, Cisplatin and 5 FU Followed by Radiotherapy With Cetuximab for Locally Advanced or Not Resectable Carcinoma of the Head and Neck', 'orgStudyIdInfo': {'id': 'AGMT_HNO 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) and 5-fluorouracil (750mg/m²) followed by Cetuximab (weekly, starting with 400mg/m² then continuing with 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).\n\nActive comparator is 5-fluorouracil for first three cycles.', 'interventionNames': ['Drug: Docetaxel', 'Drug: Cisplatin', 'Drug: 5-fluorouracil', 'Biological: Cetuximab Radioimmunotherapy', 'Radiation: Boost irradiation']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'All patients receive 3 cycles (cycle duration 21 days) of docetaxel (75mg/m²), cisplatin (75mg/m²) Cetuximab (weekly, starting with 400mg/m² and continuing with 250 mg/m²), followed by Cetuximab (weekly 250 mg/m²) with radiotherapy (concomitant boost for 6 weeks).\n\nExperimental: cetuximab for the first three cycles.', 'interventionNames': ['Drug: Docetaxel', 'Drug: Cisplatin', 'Biological: Cetuximab Induction', 'Biological: Cetuximab Radioimmunotherapy', 'Radiation: Boost irradiation']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'description': '75 mg/m² on day 1 of 21-days cycle', 'armGroupLabels': ['A', 'B']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': '75 mg/m² on day 1 of 21-days cycle', 'armGroupLabels': ['A', 'B']}, {'name': '5-fluorouracil', 'type': 'DRUG', 'description': '750 mg/m² day 1 to 5 during 24 hours of 21-days cycle', 'armGroupLabels': ['A']}, {'name': 'Cetuximab Induction', 'type': 'BIOLOGICAL', 'otherNames': ['Erbitux'], 'description': 'weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days', 'armGroupLabels': ['B']}, {'name': 'Cetuximab Radioimmunotherapy', 'type': 'BIOLOGICAL', 'otherNames': ['Erbitux'], 'description': 'weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks', 'armGroupLabels': ['A', 'B']}, {'name': 'Boost irradiation', 'type': 'RADIATION', 'otherNames': ['Concomitant boost-irradiation'], 'description': 'First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6807', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Landeskrankenhaus Feldkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': 'A-3500', 'city': 'Krems', 'country': 'Austria', 'facility': 'Landesklinikum Krems', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': 'A-4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'Krankenhaus d. Barmherzigen Schwestern Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitätsklinikum, Med Campus III. Klinik für Interne 3 - Schwerpunkt Hämatologie u. Onkologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'PMU Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Hanusch Krankenhaus Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Universität f. Strahlentherape, AKH Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A-4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Kreuzschwestern Wels GmbH', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}], 'overallOfficials': [{'name': 'Felix Keil, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanuschkrankenhaus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}